Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Shire Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 17 August 2015, a delegate of the Secretary of the Department of Health, on the application of Shire Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of

• esterase inhibitor (CINRYZE C1) 500 units powder for solution for injection vial with diluent vial [AUST R 177513]

that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for labels for medicines, in that the product will bear existing artwork labels with Viropharma Pty Ltd as sponsor/supplier despite the transfer of sponsorship to                Shire Australia Pty Ltd (ID-51186) on 23rd July 2015.

The consent is effective from 17 August 2015 until 31 December 2016.

The consent is subject to the following conditions:

1. The labels to which this consent applies are those previously approved for the former sponsor Viropharma Pty Ltd (ID: 58619) and arrangements are in place for prompt referral of any queries or complaints concerning the products to Shire Australia Pty Ltd, the current sponsor.
2. An assurance that submission will be made to the Therapeutic Goods Administration as soon as possible to update the labels with Shire’s details.
3. An assurance that apart from the details nominated in the application no other changes have been made to the product.